imc 1246, appendix e1, 'training requirements and

Issue Date: 10/26/11 E1-1 1246

APPENDIX E1

TRAINING REQUIREMENTS AND QUALIFICATION JOURNAL FOR MATERIALS LICENSE REVIEWER

Note: The Materials License Reviewer is a qualification in the Office of Federal and State Materials Environmental Management Programs. The contents of this Appendix were merged from IMC 1246 Appendix A Section I and Appendix B Section I published on January 5, 2001. No changes were made to the training requirements or qualification journal since they were published on January 5, 2001.

Issue Date: 10/26/11 E1-2 1246

APPENDIX E1 TRAINING REQUIREMENTS FOR MATERIALS LICENSE REVIEWER A.APPLICABILITY The training described below is required for all materials license reviewers assigned to perform radiological safety reviews of nuclear material license applications, except exempt distribution licenses, fuel cycle licenses, and licenses issued by the NMSS Division of Waste Management. B. TRAINING

1. Required Initial Training

a. Self Study and on-the job Training

(1) NRC Orientation

(2) Code of Federal Regulations

(3) Office Instructions/Regional Procedures

(4) Regulatory Guidance

(5) NRC Inspection Manual

(6) Industry Codes and Standards

(7) Required Licensing Site Visits to Core Licensees

(8) NRC Management Directives

(9) Review of significant events at materials licensees

(10) Directed Review of Selected Licensing Case Work

b. Core Training. These courses establish minimum formal classroom training requirements. Refer to Section 1246-08 for exceptions to these requirements.

(1) Health Physics Technology Course (H-201)

(2) Diagnostic and Therapeutic Nuclear Medicine Course (H-304)

(3) Safety Aspects of Industrial Radiography Course (H-305)

(4) Teletherapy and Brachytherapy Course (H-313)

(5) Licensing Practices and Procedures Course (G-109)

(6) Transportation of Radioactive Materials Course (H-308)

Issue Date: 10/26/11 E1-3 1246

(7) NMSS Radiation Worker Training (H-102)

c. Specialized Training. Depending on the materials license reviewer's

previous work experience and planned reviewer activities, additional courses may be required in order to gain knowledge necessary for specialized licensing activities. Management will make this determination on an individual basis. For example, if a license reviewer is assigned activities in one of the areas listed below then that reviewer should attend the appropriate training course or have equivalent experience as determined by their management.

(1) Fundamentals of Inspection Course (G-101) or Inspection

Procedures Course (G-108)

(2) Internal Dosimetry & Whole Body Counting Course (H-312)

(3) Safety Aspects of Well Logging Course (H-314)

(4) Irradiator Technology Course (H-315)

(5) Environmental Monitoring for Radioactivity Course (H-111)

(6) Air Sampling for Radioactive Material Course (H-119)

(7) Site Access Training (H-100)

2. Supplemental Training. Additional training beyond that identified as Core Training. This training will be determined by the individual's supervisor and will depend on the individual's previous work experience and planned inspection or licensing activities in specific areas.

3. Refresher Training. Refresher training will be conducted every three years

following initial certification. Refresher training will include the following course and other courses as determined by management:

a. Health Physics Topical Review Course (H-401)

END

Issue Date: 10/26/11 E1-4 1246

MATERIALS LICENSE REVIEWER NRC LICENSE REVIEWER QUALIFICATION JOURNAL Applicability This NRC License Reviewer Qualification Journal implements NRC Manual Chapter 1246, by establishing the minimum training requirements for personnel assigned to perform license reviews for materials facilities. The NRC License Reviewer Qualification Journal serves as a guideline for the development of a Qualification Journal, and establishes the minimum training requirements consistent with NRC Manual Chapter 1246. The Qualification Journal must provide traceable documentation to show that minimum requirements are met for each license reviewer. The NRC License Reviewer Qualification Journal consists of a series of qualification guides and signature cards. Each signature card is used to document task completion, as indicated by the appropriate signature blocks. The corresponding qualification guide establishes the minimum knowledge levels or areas of study that must be completed for each signature card. Most of the qualification guides are divided into sections. The review sections of the qualification guides identify references with general application to the license reviewer's qualification. The license reviewer is expected to have a general familiarity with these references. Other sections of the qualification guides identify specific references that have direct application to the license review discipline. The license reviewer is expected to demonstrate detailed knowledge of the license review specific references. In order to support the review of upper tier documents, programs, and policies, the license reviewer's immediate supervisor will assign one or more specific materials licensees as reference licensees. The selection of reference licensees is intended to provide the license reviewer's management with the ability to tailor the qualification process to the experience and training level of the license reviewer, and to meet the needs of the NRC. The use of specific real world material will reinforce the qualification process.

Issue Date: 10/26/11 E1-5 1246

LICENSE REVIEWER QUALIFICATION JOURNAL - Materials License Reviewer (Name) (Title) (Branch) (Section) To complete your qualification as a Materials License Reviewer you are to complete the following signature cards. All signoffs shall include the signature of the responsible reviewer and the date. Maintain these cards in a notebook along with any background or written material required by the program. This notebook will comprise your NRC License Reviewer Qualification Journal.

Signature When Complete Date 1. NRC Orientation

First Line Supervisor 2. Code of Federal Regulations

First Line Supervisor 3. Office Instructions/Regional

Procedures First Line Supervisor

4. Regulatory Guidance

First Line Supervisor 5. NRC Inspection Manual

Chapter (MC) First Line Supervisor 6. Industry Codes and Standards First Line Supervisor 7. Required Licensing Site

Visits to Core Licensees First Line Supervisor 8. NRC Management Directives

First Line Supervisor 9. Review of Significant Events

at Materials Licensees First Line Supervisor

10. Directed Review of Selected

Licensing Case Work First Line Supervisor

11. Formal Training

First Line Supervisor

Issue Date: 10/26/11 E1-6 1246

Qualification Board

Requirement Met Second Level Supervisor or Board Chairman

Recommended as a qualified license reviewer

Second Level Supervisor Certification Memo Issued

Second Level Supervisor

Issue Date: 10/26/11 E1-7 1246

Qualification Card 1 NRC Orientation A. Site Orientation Initials Date

1. New employee processing package completed

Employee

2. Facility tour and introduction

First Line Supervisor B. NRC Organization

1. Review of NRC headquarters and regional organization

Employee

2. Discussion of NRC organization First Line Supervisor

Issue Date: 10/26/11 E1-8 1246

Qualification Card 2 Code of Federal Regulations (CFR)

Initials Date A. Familiarization with selected

CFR parts completed Employee

B. Discussion completed on CFR

parts related to the materials license review program


Issue Date: 10/26/11 E1-9 1246

Qualification Card 3 Office Instructions/Regional Procedures

Initials Date A. Familiarization with office/ regional policies and procedures

Employee B. Discussion completed on office/ regional policies and procedures


Issue Date: 10/26/11 E1-10 1246

Qualification Card 4 Regulatory Guidance

Initials Date A. Review of regulatory guidance

1. Regulatory Guides Employee

2. Information Notices

/Bulletins Employee

3. NUREGs

Employee

4. Generic Letters Employee

5. Federal Register Notices

Employee

6. NRC Branch Technical Positions Employee

7. Policy and Guidance Directives

Employee

8. Standard Deficiency Paragraphs Employee

9. Standard License Conditions

Employee

10. Licensing Checklists Employee

11. Standard Review Plans

Employee

12. Sealed Source and Device Registry

Employee

13. Technical Assistance Requests Employee

B. Discussion of regulatory guidance

with application to the materials license review program


Issue Date: 10/26/11 E1-11 1246

Qualification Card 5 NRC Inspection Manual Chapters (MC)

Initials Date A. Review of appropriate

portions of NRC MCs completed

Employee B. Discussion of NRC MCs

and its relation to the materials license review program


Issue Date: 10/26/11 E1-12 1246

Qualification Card 6 Industry Codes and Standards

Initials Date A. Review of selected codes

and standards completed Employee

B. Discussion of the application

of codes and standards in the materials license review program


Issue Date: 10/26/11 E1-13 1246

Qualification Card 7 Required (As Appropriate) Licensing Site Visits to Core Licensees

Initials Date A. Site visits completed

1. Facility Employee




B. Review and discussion by first line

supervisor of licensing site visits and their relation to the materials license review program

1.

Facility First Line Supervisor

2.

_________ Facility First Line Supervisor

3. Facility First Line Supervisor

4. Facility First Line Supervisor

Issue Date: 10/26/11 E1-14 1246

Qualification Card 8 NRC Management Directives

Initials Date A. Review of selected portions of

the NRC Management Directives completed

Employee B. Discussion of the application

of the NRC Management Directives to the materials license review program


Issue Date: 10/26/11 E1-15 1246

Qualification Card 9 Review of Significant Events at Materials Licensees

Initials Date A. Review of selected significant

historical materials events Employee

B. Discussion of the importance

of these events and lessons learned First Line Supervisor

Issue Date: 10/26/11 E1-16 1246

Qualification Card 10 Directed Review of Selected Licensing Case Work

Initials Date A. Review of selected licensing

casework

1. __________________ _______________ _______ (Case Study) Employee

2. __________________ _______________ ________

(Case Study) Employee

3. __________________ _______________ ________ (Case Study) Employee

4. __________________ _______________ ________

(Case Study) Employee B. Discussion by first line super-

visor of directed review of the selected casework and its relation to the materials license review program.

1. __________________ _____________________ ________

(Case Study) First Line Supervisor

2. __________________ _____________________ ________ (Case Study) First Line Supervisor

3. __________________ _____________________ ________

(Case Study) First Line Supervisor

4. __________________ _____________________ ________ (Case Study) First Line Supervisor

Issue Date: 10/26/11 E1-17 1246

Qualification Card 11 Formal Training A. CORE TRAINING: Initials Date 1. Health Physics Technology

Course (H-201) ____________________ _____ Training Coordinator

2. Diagnostic and Therapeutic

Nuclear Medicine Course (H-304) ____________________ _____ Training Coordinator

3. Safety Aspects of Industrial

Radiography Course (H-305) ____________________ _____ Training Coordinator

4. Teletherapy and Brachytherapy

Course (H-313) ____________________ _____ Training Coordinator

5. Licensing Practices and Procedures

Course (G-109) ____________________ _____ Training Coordinator

6. Transportation of Radioactive

Materials Course (H-308) ____________________ _____ Training Coordinator

7. NMSS Radiation Worker Training

Course (H-102) Training Coordinator

B. SPECIALIZED TRAINING: Other specialized training courses required for license reviewers performing licensing activities in specific areas:

Course Title Course # Initials Initials Date

____________ __________ ___________ ___________________ ______

Supervisor Training Coordinator

____________ _________ ___________ Supervisor Training Coordinator

____________ _________ ___________



Issue Date: 10/26/11 E1-18 1246

Qualification Guide 1 NRC Orientation A. Site Orientation

1. The qualifying individual should read and complete, as appropriate, the following forms for processing into the NRC:

a. Personnel information

b. Health insurance elections

c. Retirement plan elections

d. Savings elections (e.g. U.S. Savings Bonds, TSP, etc.)

e. Fitness for Duty requirements and physical examination

f. Any other forms which may be required by NRC Office of Human

Resources

g. Forms for issuance of tagged, controlled NRC equipment

h. Payroll forms and time cards

i. Regulatory Information Tracking System (RITS)

2. The First Line Supervisor should orient the qualifying individual to the facility as follows:

a. Tour the facility and introduce the qualifying individual to the staff

b. Indicate to the qualifying individual the location of controlled documents,

reference material, supplies, office equipment, classrooms, etc. B. NRC Organization

1. The qualifying individual should review and become familiar with:

a. Organizational charts of division, NMSS, regions and headquarters and overall NRC organization (NUREG 0325)

b. Role of Headquarters in policy and interpretation of regulations

c. Role of NRC General Counsel

d. Role of NRC Inspector General

e. Role of NRC Public Affairs

f. Role of NRC Office of Investigations

g. Role of NRC Office of Enforcement

h. Physical location of NRC offices and regions

Issue Date: 10/26/11 E1-19 1246

i. Role of NRC as a regulatory agency

(1) 10 CFR Part 1 (Organization)

(2) Atomic Energy Act of 1954, as amended

(3) Energy Reorganization Act of 1974, as amended

(4) NRC Enforcement Policy (NUREG 1600)

(5) Incident Response Plan (NUREGs 0728 and 0845)

(6) Energy Policy Act of 1992

2. The First Line Supervisor should discuss NRC organization and role with the qualifying individual to ensure the qualifying individual has a full understanding of NRC's organization and mission and the role of the license reviewer in that mission.

Issue Date: 10/26/11 E1-20 1246

Qualification Guide 2 Code of Federal Regulations (CFR) A. A selection of currently applicable CFR Parts should be made by the First Line

Supervisor. The selection should include the references listed below and be documented. The qualifying individual should be expected to have a general knowledge of the topics addressed in the references. This review may be accomplished by self-study, study-quizzes, briefings, or discussions.

1. 10 CFR Part 1 Statement of organization and general information

2. 10 CFR Part 2 Rules of practice for domestic licensing proceedings and

issuance of orders

3. 10 CFR Part 9 Public Records

4. 10 CFR Part 19 Notices, instructions and reports to workers; inspections

5. 10 CFR Part 20 Standards for protection against radiation (includes selected Questions and Answers, Q & As)

6. 10 CFR Part 21 Reporting of defects and noncompliance

7. 10 CFR Part 30 Rules of general applicability to domestic licensing of

byproduct material

8. 10 CFR Part 31 General domestic licenses for byproduct material

9. 10 CFR Part 32 Specific domestic licenses to manufacture or transfer certain items containing byproduct material

10. 10 CFR Part 33 Specific domestic licenses of broad scope for byproduct

material

11. 10 CFR Part 34 Licenses for radiography and radiation safety requirements for radiographic operations

12. 10 CFR Part 35 Medical use of byproduct material

13. 10 CFR Part 36 Licenses and radiation safety requirements for irradiators

14. 10 CFR Part 39 Licenses and radiation safety requirements for well

logging

15. 10 CFR Part 40 Domestic licensing of source material

16. 10 CFR Part 61 Licensing requirements for land disposal of radioactive waste

17. 10 CFR Part 70 Domestic licensing of special nuclear material

18. 10 CFR Part 71 Packaging and transportation of radioactive material

19. 10 CFR Part 150 Exemptions and continued regulatory authority in

agreement states and in offshore waters under section 274

Issue Date: 10/26/11 E1-21 1246

20. 10 CFR Part 170 Fees for facilities, materials, import and export licenses

and other regulatory services under the Atomic Energy Act of 1954, as amended

21. 10 CFR Part 171 Annual fees for reactor operating licenses, and fuel

cycle licenses and materials licenses, including holders of certificates of compliance, registrations, and quality assurance program approvals and government agencies licensed by NRC

22. 29 CFR Part 1910 Occupational Safety and Health Standards

23. 40 CFR Part 61 National Emission Standards for Hazardous Air

Pollutants (emphasis on Subpart I)

24. 40 CFR Part 141 National Primary Drinking Water Regulations 25. 49 CFR Parts 171 Transportation

through 180

26. 40 CFR Part 190 Environmental Radiation Protection for Nuclear Power Operations (Uranium Fuel Cycle Standards)

27. 10 CFR Part 110 Export and Import of Nuclear Material and

Equipment B. Following completion of the qualifying individual=s self study of the listed 10 CFR

Parts, a discussion will be held with the qualifying license reviewer by the First Line Supervisor to test the qualifying license reviewer=s knowledge of these Parts. To the extent possible, recent application of various sections, new regulatory initiatives, and current industry issues should be emphasized.

Issue Date: 10/26/11 E1-22 1246

Qualification Guide 3 Office Instructions/Regional Procedures A. Office/Region Policies and Procedures

1. Read the Region Policy and Procedures Manual

2. The qualifying individual should review the division/NRC policies and practices on:

a. Travel, including Management Directive 14.1 Official Temporary Duty

Travel

b. Telephone use

c. Policies on use of annual leave and sick leave and excused leave, including Bulletin 4135, Leave Administration

d. Work schedule, including NRC Appendix 4136, Hours of Work and

Premium Pay

e. Use of government equipment, including computers (ADAMS & NUDOCS) and Management Directive 13.1, Property Management

f. Union activities, including Management Directive 10.102,

Lqabor-Management Relations Program for Federal Employees

g. Communications outside NRC

h. Policies on outside employment and acceptance of gifts

i. Participation in political activities

j. Routing of mail and procedures for sending mail and materials (via U.S. Mail, Federal Express, etc.), including Management Directive 3.23, Mail Management

k. Ordering of documents (e.g NUREGs)

l. Division emergency and evacuation procedures

m. Employee appraisal system and Individual Development Plan (IDP)

(1) Employee trial period (Management Directive 10.14 Employment and

Staffing)

(2) Employee appraisals (Management Directive 10.67, Non-SES Performance Appraisal System)

n. Differing Professional Views or Opinions (Management Directive 10.159,

General Personnel Management Provisions)

Issue Date: 10/26/11 E1-23 1246

B. The First Line Supervisor should discuss these policies and practices with the qualifying individual to ensure that the qualifying individual has a full and complete understanding.

Issue Date: 10/26/11 E1-24 1246

Qualification Guide 4 Regulatory Guidance A. A selection of currently applicable regulatory guidance should be identified by the

First Line Supervisor. These references should include those listed below (documents marked by an asterisk must be selected as a minimum) and should be documented. The qualifying individual should be expected to have a general knowledge of the topics addressed in the references. The review may be accomplished by self-study, study-quizzes, briefings, or discussions. Note that many Regulatory Guides reference or endorse industry codes and standards listed in Qualification Guide 6. Study of corresponding and subtier codes and standards is recommended.

` 1. Regulatory Guides (use latest revision)

4.6 Measurements of Radionuclides in the Environment - Strontium-89

and Strontium-90 Analyses

4.13 Performance, Testing and Procedural Specifications for Thermoluminescence Dosimetry: Environmental Applications

4.15 Quality Assurance for Radiological Monitoring Programs

4.20 Constraint on Releases of Airborne Radioactive Materials to the

Environment for Licensees other than Power Reactors.

*6.1 Leak Testing Radioactive Brachytherapy Sources 6.2 Integrity and Test Specifications

6.3 Design, Construction, and Use of Radioisotopic Power Generators for

Certain Land and Sea Applications

6.4 Classifications of Containment Properties of Sealed Radioactive Sources

*6.5 General Safety Standard for Installations Using Nonmedical Sealed

Gamma Ray Sources

6.6 Acceptance Sampling Procedures for Exempted and Generally Licensed Items Containing Byproduct Material

6.7 Preparation of an Environmental Report to Support a Rule Making

Petition Seeking an Exemption for a Radionuclide-Containing Product

6.8 Identification Plaque for Irretrievable Well-Logging Sources

6.9 Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources and Devices containing Byproduct Material

7.1 Administrative Guide for Packaging and Transporting Radioactive

Material

*7.2 Packaging and Transportation of Radioactively Contaminated Biological Materials

Issue Date: 10/26/11 E1-25 1246

*7.3 Procedures for Picking Up and Receiving Packages of Radioactive

Material

*7.4 Leakage Tests on Packages for Shipment of Radioactive Materials

7.5 Administrative Guide for Obtaining Exemptions from Certain NRC Requirements over Radioactive Material Shipments

*7.7 Administrative Guide for Verifying Compliance with Packaging

Requirements for Shipments of Radioactive Materials

7.10 Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material

*8.1 Radiation Symbol

*8.2 Guide for Administrative Practices in Radiation Monitoring

*8.4 Direct Reading and Indirect Reading Pocket Dosimeters

8.5 Criticality and Other Interior Evacuation Signals

*8.6 Standard Test Procedure for Geiger Muller Counters

*8.7 Instructions for Recording and Reporting Occupational Radiation

Exposure Data

*8.9 Acceptable Concepts, Models, Equations and Assumptions for a Bioassay Program

*8.10 Operating Philosophy for Maintaining Occupational Radiation

Exposures As Low As Is Reasonably Achievable

8.11 Applications of Bioassay Uranium

*8.13 Instruction Concerning Prenatal Radiation Exposure

*8.14 Personnel Neutron Dosimeters

*8.15 Acceptable Programs for Respiratory Protection

*8.18 Information Relevant to Ensuring that Occupational Radiation Exposures at Medical Institutions Will be As Low As Reasonably Achievable

*8.20 Applications of Bioassay for I-125 and I-131

*8.21 Health Physics Surveys for Byproduct Material at NRC Licensed

Processing and Manufacturing Plants

8.22 Bioassay at Uranium Mills

*8.23 Radiation Safety Surveys at Medical Institutions

8.24 Health Physics Surveys During Enriched Uranium 235 Processing and Fuel Fabrication

Issue Date: 10/26/11 E1-26 1246

*8.25 Air Sampling in the Workplace

8.26 Applications of Bioassay for Fission and Activation Products

*8.28 Audible Alarm Dosimeters

*8.29 Instruction Concerning Risks form Occupational Radiation

Exposure

8.30 Health Physics Surveys in Uranium Mills 8.31 Information Relevant to Ensuring that Occupational Radiation

Exposures at Uranium Mills Will Be As Low As Reasonably Achievable

*8.32 Criteria for Establishing a Tritium Bioassay Program

*8.33 Quality Management Program

*8.34 Monitoring Criteria and Methods to Calculate Occupational

Radiation Doses

*8.35 Planned Special Exposures

*8.36 Radiation Doses to the Embryo/Fetus

*8.37 ALARA Levels For Effluents From Materials Facilities

*8.39 Release of Patients Administered Radioactive Materials

*10.4 Guide for the Preparation of Applications for Licenses to Process Source Material

10.12 Preparation of Petitions for Rulemaking Under 10 CFR 2.802

and Preparation and Submission of Proposals for Regulatory Guidance Documents

2. Information Notices (IN) and Bulletins (BL)

IN 91-002 Brachytherapy Source Management

IN 91-003 Management of Wastes Contaminated With Radioactive

Materials ("Red Bag" Waste and Ordinary Trash)

IN 91-014 Recent Safety-Related Incidents at Large Irradiators

IN 91-023 Accidental Radiation Overexposures to Personnel Due to Industrial Radiography Accessory Equipment Malfunctions

IN 91-030 Inadequate Calibration of TLDs Utilized to Monitor Extremity

Dose at Uranium Processing and Fabrication Facilities

IN 91-035 Labeling Requirements for Transporting Multi-Hazard Radioactive Materials

IN 91-049 Enforcement of Safety Requirements for Radiographers

Issue Date: 10/26/11 E1-27 1246

IN 91-060 False Alarms of Alarm Ratemeters Because of Radiofrequency Interference

IN 91-071 Training and Supervision of Individuals Supervised by an

Authorized User

IN 92-010 Brachytherapy Incidents Involving Iridium-192 Wire Used in Endobronchial Treatments

IN 92-034 New Exposures Limits for Airborne Uranium and Thorium

IN 92-062 Emergency Response Information Requirements for

Radioactive Material Shipments

IN 92-072 Employee Training and Shipper Registration Requirements forTransporting Radioactive Materials

IN 92-084 Release of Patients Treated With Temporary Implants

IN 93-004 Investigation and Reporting of Misadministrations by the

Radiation Safety Officer

IN 93-005 Locking of Radiography Exposure Devices

IN 93-006 Potential Bypass Leakage Paths Around Filters Installed in Ventilation Systems

IN 93-007 Classification of Transportation Emergencies

IN 93-010 Dose Calibrator Quality Control

IN 93-014 Clarification of 10 CFR 40.22, Small Quantities of Source

Material

IN 93-018 Portable Moisture-Density Gauge User Responsibilities During Field Operations

IN 93-030 NRC Requirements for Evaluation of Wipe Test Results;

Calibration of Count Rate Survey Instruments

IN 93-031 Training of Nurses Responsible for the Care of Patients With Brachytherapy Implants

IN 93-036 Notifications, Reports, and Records of Misadministrations

IN 93-060 Reporting Fuel Cycle and Materials Events to the NRC

Operations Center

IN 93-069 Radiographic Events At Operating Power Reactors

IN 93-100 Reporting Requirements for Bankruptcy

IN 94-007 Solubility Criteria For Liquid Effluent Releases to Sanitary Sewerage Under the Revised 10 CFR Part 20

IN 94-009 Release of Patients With Residual Radioactivity From Medical

Treatment and Control Areas ... Revised 10 CFR Part 20

Issue Date: 10/26/11 E1-28 1246

IN 94-015 Radiation Exposures During an Event Involving a Fixed Nuclear

Gauge

IN 94-016 Recent Incidents Resulting in Offsite Contamination

IN 94-017 Strontium-90 Eye Applicators: Submission of Quality Management Plan (QMP), Calibration, and Use

IN 94-037 Misadministration Caused By a Bent Interstitial Needle During

Brachytherapy Procedure

IN 94-039 Identified Problems in Gamma Stereotactic Radiosurgery

IN 94-047 Accuracy of Information Provided to NRC During the Licensing Process

IN 94-065 Potential Error in Manual Brachytherapy Dose Calculations

Generated Using a Computerized Treatment Planning System

IN 94-070 Issues Associated with the Use of Strontium-89 and Other Beta Emitting Radiopharmaceuticals

IN 94-074 Facility Management Responsibilities for Purchased or

Contracted Services for Radiation Therapy Programs

IN 94-081 Accuracy of Bioassay and Environmental Sampling Results

IN 95-007 Radiopharmaceutical Vial Breakage During Preparation

IN 95-025 Valve Failure During Patient Treatment with Gamma Stereotactic Radiosurgery Unit

IN 95-039 Brachytherapy Incidents Involving Treatment Planning Errors

IN 95-050 Safety Defect in Gammamed 12I Bronchial Catheter Clamping

Adapters

IN 95-051 Recent Incidents Involving Potential Loss of Control of Licensed Material

IN 96-004 Incident Reporting Requirements for Radiography Licensees

IN 96-035 Failure of Safety Systems on Self-Shielded Irradiators Because

of Inadequate Maintenance and Training

IN 96-047 Recordkeeping, Decommissioning Notifications for Disposals of Radioactive Waste by Land Burial Authorized under Former 10 CFR 20.304, 20.302, and Current 20.2002

IN 96-057 Incident-reporting Requirements Involving Intakes During a

24-hour Period That May Cause a Total Effective Dose Equivalent in Excess of 0.05 SV (5 rems)

IN 96-066 Recent Misadministrations Caused by Incorrect Calibrations of

Strontium-90 Eye Applicators

Issue Date: 10/26/11 E1-29 1246

IN 96-072 Undetected Failures That May Occur During Patient Treatments with Teletherapy Devices

IN 97-030 Control of Licensed Material During Reorganizations,

Employee-Management Disagreements, and Financial Crises

IN 97-042 Management Weaknesses Resulting in Failure to Comply With Shipping Requirements for Special Nuclear Material

IN 97-043 License Condition Compliance

IN 97-055 Calculation of Surface Activity for Contaminated Equipment

and Material

IN 97-065 Failures of High-Dose-Rate Remote Afterloading (HDR) Device Source Guide Tubes, Catheters, and Applicators

IN 97-075 Enforcement Sanctions Issued as a Result of Deliberate

Violations of NRC Requirements

IN 97-091 Recent Failures of Control Cables Used on Amersham Model 660 Posilock Radiography Systems

IN 98-001 Thefts of Portable Gauges

IN 98-004 Enforcement Sanctions for Deliberate Violations of NRC

Employee Protection Requirements

IN 98-005 Criminal History Record Information

IN 98-006 Unauthorized Use of License to Obtain Radioactive Materials, and its Implications under Expanded Title 18 of the U.S.Code

IN 98-010 Probable Misadminstrations Occurring During Intravascular Brachytherapy with Novoste Beta-Cath System

IN 98-012 Licensee=s Responsibilities Regarding Reporting and Follow-Up

Requirements for Nuclear-Powered Pacemakers

IN 98-018 Recent Contamination Incidences Resulting From Failure to Perform Adequate Surveys

IN 99-004 Unplanned Radiation Exposures to Radiographers, Resulting

from Failures to Follow Proper Radiation Safety Procedures

IN 99-009 Problems Encountered When Manually Editing Treatment Data on the Nucletron Microselectron-HDR (New) Model 105.999

IN 99-11 Incidents Involving the Use of Radioactive Iodine-131

IN 99-24 Broad-Scope Licensees' Responsibilities for Reviewing and

Approving Unregistered Sealed Sources and Devices

IN 99-27 Malfunction of Source Retraction Mechanism in Cobalt-60 Teletherapy Treatment Units

BL 86-004 Defective Teletherapy Timer That May Not Terminate

Treatment Dose

Issue Date: 10/26/11 E1-30 1246

BL 88-006 Actions To Be Taken for the Transportation of Model No. SPEC

2-T Radiographic Exposure Device

BL 92-002 Safety Concerns Related to "End of Life" of Aging Theratronics Teletherapy Units

BL 92-003 Release of Patients After Brachytherapy

BL 93-001 Release of Patients After Brachytherapy Treatment With

Remote Afterloading Devices

BL 95-001 Quality Assurance Program For Transportation of Radioactive Material

BL 97-001 Potential for Erroneous Calibration, Dose Rate, or Radiation

Exposure Measurements with Certain Victoreen Model 530 and 530SIElectrometer/Dose-Meters

Others as selected by the First Line Supervisor

3. NUREGs (latest revision, where applicable)

NUREG 1400 Air Sampling in the Workplace

NUREG 1460 Guide to NRC Reporting and Recordkeeping Requirements

NUREG 1507 Minimum Detectable Concentrations with Typical Radiation

Survey Instruments for Various Contaminants and Field Conditions

NUREG 1556 Consolidated Guidance About Materials Licenses

Vol. 1: Program-Specific Guidance About Portable Gauge Licenses

Vol. 2: Program-Specific Guidance About Industrial Radiography Licenses

Vol. 3: Applications for Sealed Source and Device Evaluation and

Registration

Vol. 4: Program-Specific Guidance About Fixed Gauge Licenses

Vol. 5: Program-Specific Guidance About Self-Shielded Irradiator Licenses

Vol. 6: Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses

Vol. 7: Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope

Vol. 8: Program-Specific Guidance About Exempt Distribution Licenses

Vol. 9: Program-Specific Guidance About Medical Use Licenses

Vol. 10: Program-Specific Guidance About Master Material Licenses

Vol. 11: Program-Specific Guidance About Licenses of Broad Scope

Issue Date: 10/26/11 E1-31 1246

Vol. 12: Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution

Vol. 13: Program-Specific Guidance About Commercial Radiopharmacy

Licenses

Vol. 14: Program-Specific Guidance About Well Logging, Tracer, and Field Flood Study Licenses

Vol. 15: Program-Specific Guidance About About Changes of Control and

About Bankruptcy Involving Byproduct, Source, or Special Nuclear Material Licenses

Vol. 16: Program-Specific Guidance About Licenses Authorizing Distribution

to General Licensees

Vol. 17: Program-Specific Guidance About Service Provider Licenses

Vol. 18: Program-Specific Guidance About Special Nuclear Material of Less than Critical Mass Licenses

Vol. 19: Guidance For Agreement State Licensees About NRC Form 241,

Report of Proposed Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, or Offshore Waters, and Guidance for NRC Licensees Proposing to Work in Agreement State Jurisdiction (Reciprocity)

Vol. 20: Program-Specific Guidance About Administrative Licensing

Procedures

NUREG 1575 Multi-Agency Radiation Site Survey and Investigation Manual (MARSSIM)

NUREG 1600 General Statement of Policy and Procedures for NRC

Enforcement Actions

NUREG/BR 0195 NRC Enforcement Manual

NUREG/BR 0216 Radioactive Waste: Production, Storage, Disposal

NUREG/BR 0240 Reporting Safety Concerns

NUREG/BR 0241 NMSS Handbook for Decommissioning Fuel Cycle and Materials Licenses

NUREG/CR 4884 Interpretation of Bioassay Measurements

NUREG/CR 5849 Manual for Conducting Radiological Surveys in Support of

License Termination


4. Generic Letters

GL 86-011 Distribution of Products Irradiated in Research Reactors

Issue Date: 10/26/11 E1-32 1246

GL 88-004 Distribution of Gems Irradiated In Research Reactors

GL 94-004 Voluntary Reporting of Additional Occupational Radiation Exposure Data

GL 95-09 Monitoring and Training of Shippers and Carriers of Radioactive

Material

GL 99-001 Recent Nuclear Materials Safety and Safeguards Decision on Bundling Exempt Sources


5. Federal Register Notices

U. S. Nuclear Regulatory Commission, "Decommissioning, Recordkeeping and License Termination: Documentation Additions - Final Rule," Federal Register 58 (No. 141), 39628-39635, July 26, 1993

U. S. Nuclear Regulatory Commission, "General Requirements for Decommissioning Nuclear Facilities - Final Rule, Federal Register 53 (No. 123), 24018-24056, June 27, 1988


6. NRC Branch Technical Positions

Guidelines for Decontamination of Facilities and Equipment Prior to Release for Unrestricted Use or Termination of Licenses for Byproduct, Source, or Special Nuclear Material, April 1993

7. Policy and Guidance Directives

8. Standard Deficiency Paragraphs

9. Standard License Conditions

10. Licensing Checklists

11. Standard Review Plans 12. Sealed Source and Device Registry

13. Technical Assistance Requests

7. Through 13. as selected by the First Line Supervisor B. The application of these guidance documents to the materials license review

program should be studied in detail by the qualifying individual and covered by the First Line Supervisor in discussions, interviews, or oral quizzes.

Issue Date: 10/26/11 E1-33 1246

Qualification Guide 5 NRC Inspection Manual Chapters(MC) A. A selection of currently applicable NRC MC and Inspection Procedure (IP)

references with direct application to the materials license review program should be identified by the First Line Supervisor. The application of the specific sections to the materials license review program should be studied in detail by the qualifying individual.

1. REPORTS/COMMUNICATIONS/FOLLOW-UP

MC 0230 Morning Report MC 0610 Inspection Reports MC 0620 Inspection Documents and Records MC 0720 NRC Bulletins and Information Notices MC 0801 Inspector Feedback MC 1120 Preliminary Notifications

IP 92701 Followup IP 92703 Followup of Confirmatory Action Letters

2. INSPECTIONS

MC 0300 Announced and Unannounced Inspections MC 0312 Technical Assistance for Radiation Safety Inspections at

Nuclear Fuel Cycle Facilities and Materials Licensees= Sites MC 1246 Formal Qualification Programs in Nuclear Material Safety and

Safeguards Program Area MC 2800 Materials Inspection Program (Inspection Priorities and

Scheduling) 3. INTERACTIONS WITH OTHER FEDERAL AGENCIES

MC 1007 Interfacing Activities between Regional Offices of NRC and OSHA

IP 87102 Maintaining Effluents from Materials Facilities As Low As Is

Reasonably Achievable (ALARA) [EPA]1 4. INCIDENT RESPONSE

MC 1300 Incident Response Actions - Responsibility and Authority MC 1301 Response to Radioactive Material Incidents that Do Not

Require Activation of the NRC Incident Response Plan MC 1302 Action Levels for Radiation Exposures and Contamination

Associated with Materials Events Involving Members of the Public

MC 1330 Response to Transportation Accidents Involving Radioactive Materials

MC 1360 Use of Physician and Scientific Consultants in the Medical Consultant Program

1 Required for non-sealed source licensees.

Issue Date: 10/26/11 E1-34 1246

IP 87103 Inspection of Material Licensees Involved in an Incident or Bankruptcy

Filing 5. LOW-LEVEL WASTE/WASTE MANAGEMENT

MC 2401 Near-Surface Low-Level Radioactive Waste Disposal Facility Inspection Program

IP 84750 Radioactive Waste Treatment, and Effluent and Environmental

Monitoring IP 84850 Radioactive Waste Management - Inspection of Waste

Generator Requirements of 10 CFR Part 20 and 10 CFR Part 61 IP 84900 Low-Level Radioactive Waste Storage

6. MATERIALS SAFETY PROGRAM

MC 1220 Processing of NRC Form 241, Inspection of Agreement State Licensees Operating under the Reciprocity Provisions of 10 CFR 150.20

MC 2800Materials Inspection Program MC 2810 Materials Inspection Programs for Multisite, and Multiregional Broad

Licenses MC 2815 Construction and Preoperational Inspection of Panoramic,

Wet-Source Storage Gamma Irradiators

IP 87101 Performance Evaluation Factors IP 87102 Maintaining Effluents from Materials Facilities As Low As Is

Reasonably Achievable (ALARA) IP 87103 Inspection of Material Licensees Involved in an Incident or Bankruptcy

Filing IP 87110 Industrial/Academic/Research Programs IP 87111 Materials Processor/Manufacturer Programs IP 87112 Irradiator Programs IP 87113 Well Logging Programs IP 87114 Fixed and Portable Gauge Programs IP 87115 Nuclear Medicine Programs IP 87116 Medical Teletherapy Programs IP 87117 Radiopharmacy Programs IP 87118 Brachytherapy Programs IP 87119 Medical Broad-Scope Programs IP 87120 Industrial Radiography Programs IP 87250 Locating Missing Materials Licensees

7. RADIATION PROTECTION

MC 8300 Radiation Protection

IP 83726 Control of Radioactive Materials and Contamination, Surveys, and Monitoring

IP 83728 Maintaining Occupational Exposures ALARA IP 83750 Occupational Radiation Exposure

Issue Date: 10/26/11 E1-35 1246

IP 83822 Radiation Protection IP 83890 Closeout Inspection and Survey IP 83895 Radiation Protection - Followup on Expired Licenses

8. TRANSPORTATION

MC 1330 Response to Transportation Accidents Involving Radioactive Materials

IP 86721 Transportation (Basic) IP 86740 Inspection of Transportation Activities IP 86750 Solid Radioactive Waste Management and Transportation of

Radioactive Materials 9. OTHER

MC 0700 Communication with Licensees MC 1010 Independent Assessment and Analysis MC 1201 Conduct of Employees MC 2900 Performance Appraisal Program

B. The First Line Supervisor will hold discussions, interviews, or oral quizzes to test the

qualifying individual's knowledge and understanding of the application of the selected sections to the materials license review program.

Issue Date: 10/26/11 E1-36 1246

Qualification Guide 6 Industry Codes and Standards A. A selection of currently applicable industry codes and standards should be identified

by the First Line Supervisor. These references should include those listed below and be documented. The qualifying individual should be expected to have a general knowledge of the topics addressed in the references. This review may be accomplished by self study, study quizzes, briefings, or discussions.

1. American National Standards Institute (ANSI)

ANSI N13.1 Guide to Sampling Airborne Radioactive Materials in

Nuclear Facilities

ANSI N13.2 Guide for Administrative Practices in Radiation Monitoring

ANSI N13.5 Performance Specifications for Direct Reading and Indirect Reading Pocket Dosimeters for X and Gamma Radiation

ANSI N13.7 Criteria for Photographic Film Dosimeter Performance

ANSI N13.27 Performance Requirements for Pocket Sized Alarm

Dosimeters and Alarm Ratemeters

ANSI N42.12 Calibration and Usage of Sodium Iodide Detection Systems

ANSI N42.13 Calibration and Usage of Dose Calibrator Ionization

Chambers for the Assay of Radionuclides

ANSI N42.14 Calibration and Use of Germanium Spectrometers for the Measurement of Gamma Ray Emission Rates of Radionuclides

ANSI N42.15 Performance Verification of Liquid Scintillation Counting

Systems

ANSI N43.3 General Radiation Safety - Installations Using Non-Medical X-Ray and Sealed Gamma-Ray Sources, Energies up to 10 MeV

ANSI 43.7 Safe Design and Use of Self Contained Dry Source

Storage Gamma Irradiators (Category I)

ANSI N43.8 Classification of Industrial Ionizing Radiation Gaging Devices

ANSI N43.10 Safe Design and Use of Panoramic Wet Source Storage

Gamma Irradiators (Category IV)

ANSI N44.1 Integrity and Test Specifications for Selected Brachytherapy Sources

ANSI N44.2 Leak Testing Radioactive Brachytherapy Sources

Issue Date: 10/26/11 E1-37 1246

ANSI N44.3 Thyroid Radioiodine Uptake Measurements Using a Neck Phantom

ANSI N319 Personnel Neutron Dosimeters

ANSI N322 Inspection and Test Specifications for Direct and Indirect

Reading Quartz Fiber Pocket Dosimeters

ANSI N323 Radiation Protection Instrumentation Test and Calibration

ANSI N449 Guidelines for Maintaining Cobalt-60 and Cesium-137 Teletherapy Equipment

ANSI N449.1 Procedures for Periodic Inspection of Cobalt-60 and

Cesium-137 Teletherapy Equipment

ANSI N542 Sealed Radioactive Sources Classification

ANSI Z88.2 Practices for Respiratory Protection

ANSI Standards as selected and documented by the First Line Supervisor 2. NRC Accepted HP Computer Codes

PC-DOSE Varskin RASCAL REMIT

3. National Council on Radiation Protection and Measurements (NCRP)

NCRP Reports No. 8, 30, 37, 40, 41, 47, 49, 50, 57, 58, 59, 61, 65, 69, 70, 71, 84, 87, 93, 94, 95, 99, 100, 101, 102, 105, 107, 110, 111, 112, 114, 115, 116, 117, 121, 122, 123, 124, 125, 127, 129

NCRP Commentaries No. 9, 11

4. International Commission on Radiological Protection (ICRP)

ICRP 19, 23, 25, 26, 27, 28, 30 and Supplements, 35, 44, 51, 52, 53, 54, 56, 60, 61

5. U.S. Environmental Protection Agency (EPA)

EPA Federal Guidance Report No.11

6. Committee on the Biological Effects of Ionizing Radiation (BEIR)

BEIR Reports (As selected by supervisor)

7. International Commission on Radiological Units (ICRU)

ICRU 12, 18, 20, 22, 24, 32, 38

8. International Atomic Energy Agency (IAEA)

IAEA Safety Series No. 1, 25, 33, 38

Issue Date: 10/26/11 E1-38 1246

IAEA Technical Report Series No. 120, 133

B. The First Line Supervisor should test the qualifying individual's knowledge of

application of these codes and standards to the materials license review program by discussions, interviews, or oral quizzes.

Issue Date: 10/26/11 E1-39 1246

Qualification Guide 7 Required (As Appropriate) Licensing Site Visits to Core Licensees A. Each license reviewer shall (as appropriate) accompany certified license reviewers

on at least four site visits to core licensees. B. The following is a guide for material that should be studied and discussed with the

license reviewer in charge during these site visits. The First Line Supervisor will discuss these items, as appropriate, following each site visit.

1. The Inspection Program (as it relates to review of licenses)

MC 2800 Materials Inspection Program

2. Scheduling and Preparation for Site Visits

MC 0300 Announced and Unannounced Inspections

3. Scope of Site Visit

4. Entrance/Exit Interviews

5. Conduct of Site Visit, Accumulation of Data

6. Post-Site Visit Activities (as they relate to review of licenses)

MC 0610 Inspection Reports

MC 1100 Notification of Significant Meetings

7. Morning Reports

MC 0230 Morning Report

8. Non-routine Licensee Events

MC 1110 Potential Abnormal Occurrences

Management Directive 8.3 NRC Incident Investigation Program

Management Directive 8.10 NRC Medical Event Assessment Program

Management Directive 8.9 Accident Investigation

9. Preliminary Notification

MC 1120 Preliminary Notifications

10. Bulletins/Information Notices

MC 0720 NRC Bulletins and Information Notices

Issue Date: 10/26/11 E1-40 1246

11. Use of Consultants of NRC

MC 1360 Use of Physician and Scientific Consultants in the Medical Consultant Program

Management Directive 10.6 Use of Consultants & Experts

12. Allegations and Investigations

Management Directive 8.8 Management of Allegations

13. Communication outside NRC

Management Directive 5.5 Public Affairs Program

Management Directive 3.6 Distribution of Unclassified NRC staff/Contractor-Generated

Reports

Issue Date: 10/26/11 E1-41 1246

Qualification Guide 8 NRC Management Directives A. A selection of currently applicable NRC Management Directive (MD)references

should be identified by the First Line Supervisor. These references should include those listed below and be documented. The qualifying license reviewer should be expected to have a general knowledge of the topics addressed in the references. This review may be accomplished by self-study, study-quizzes, briefings, or discussions. The selection should include:

1. NRC MD 9.1 Organization Management

2. NRC MD 9.29 Organization and Function of Regional Offices

3. NUREG 0325 USNRC Functional Organization Chart

4. NRC MD 3.2 Privacy Act

5. NRC MD 3.1 Freedom of Information Act

6. NRC MD 10.130 Safety and Health Program Under the Occupational

Safety and Health Act

7. NRC MD 10.131 Standards for Protection Against Ionizing Radiation

8. NRC MD 14.1 Official Temporary Duty Travel

9. NRC MD 10.159 Differing Professional Views or Opinions

10. NRC MD 10.42 Hours of Work and Premium Pay

11. NRC MD 10.43 Time and Attendance Reporting

12. NRC MD 10.67 Non-SES Performance Appraisal System

13. NRC MD 10.101 Employee Grievances

14. NRC MD 8.3 NRC Incident Investigation Program

15. NRC MD 8.8 Management of Allegations

16. NRC MD 8.10 NRC Medical Event Assessment Program B. Application of the selected NRC Management Directives to the materials license

review program will be discussed with the qualifying individual by the First Line Supervisor to test the qualifying individual's knowledge.

Issue Date: 10/26/11 E1-42 1246

Qualification Guide 9 Review of Significant Events at Material Licensees A. A selection of significant historical materials related events should be identified by

the First Line Supervisor. These events should be documented and studied in detail by the qualifying individual.

B. The First Line Supervisor should discuss the selected events in detail with the

qualifying license reviewer and go over recommendations made, lessons learned, and changes identified to prevent recurrence. The relevance of the event to the overall materials license review program should be stressed.

Issue Date: 10/26/11 E1-43 1246

Qualification Guide 10 Directed Review of Selected Licensing Case Work A. The First Line Supervisor will select documents from the file of a licensed facility and

direct their review by the qualifying individual. The qualifying individual will study in detail the selected documents. The selection should be documented. Such documents would include:

1. Initial license application and facility description

2. Associated licensing correspondence (NRC staff comments and licensee

responses)

3. License renewal applications and associated NRC correspondence

4. Copy of the license

5. Inspection reports related to that licensee's activities B. The First Line Supervisor will discuss in detail with the qualifying individual the

selected documents and their relation to the overall material license review program.

Issue Date: 10/26/11 E1-44 1246

Qualification Guide 11 Formal Training The standards for each Training Course are provided in the NRC Technical Training Center Course Catalog and will not be duplicated in the Qualification Guide.

Issue Date: 10/26/11 Att1-1 1246

Attachment 1 Revision History for IMC 1246, Appendix E1

Commitment Tracking Number

Document Accession Number and Issue Date

Description of Change Training Needed

Training Completion Date

Comment Resolution Accession Number

N/A ML112350968 10/26/11 CN 11-022

Revision history sheet added. Merged with Appendix A01 and renamed as Appendix E1. Added “Training Requirements” Section from Appendix A01

None N/A ML112350982